The Consumer Healthcare Products Association submitted a citizen petition on 14 November urging the US Food and Drug Administration to exercise its existing statutory authority to swiftly issue a regulation establishing a clear pathway for manufacturers to lawfully market cannabidiol in dietary supplements. The FDA should require manufacturers of CBD-containing products to submit new dietary ingredient notifications for CBD and comply with other agency regulations, including using appropriate labeling and claims, adhering to good manufacturing practices and reporting serious adverse events, CHPA says. “NDI notifications would provide FDA with much-needed data on CBD since they must include evidence establishing a reasonable expectation of safety when used under the conditions recommended or suggested in the product’s labeling,” the association says. CHPA also asks the agency to work quickly by either issuing an interim final rule that takes effect right away or by issuing guidance on enforcement discretion for reputable manufacturers that take certain steps to ensure product quality while potentially lengthy notice-and-comment rulemaking is underway.
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